Prosthetic Joint InfectionNCT06591741
PCA Administration in Prosthetic Joint Infection
A study testing Oral PCA in people with Prosthetic Joint Infection, run by Dr. Dean Reeves Clinic at 1 site in United States.
Trial summary
Determine if dietary protocatechuic acid (PCA) will affect health biomarkers in patient undergoing revision surgery for a knee prosthetic joint infection Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Prosthetic Joint Infection
- What is being tested?
- Oral PCA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Dec 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 3 weeks or more after total knee arthroplasty
- One or more symptoms of infection, including redness, swelling, pain, increasing range of motion loss, fever, nausea, and loss of appetite.
- WBC count of aspirate >50,000 cells per μL
Who cannot join
- Not willing to undergo blood draw at 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Dietary Protocatechuic Acid (PCA) on the Function and Structure of Participants With Knee Prosthetic Joint Infection (PJI) as Measured by Standard Biomarkers
Determine if dietary protocatechuic acid (PCA) will affect health biomarkers in patient undergoing revision surgery for a knee prosthetic joint infection
Read the detailed description
Patients who are scheduled to undergo revision surgery for a knee prosthetic joint infection are given PCA prior to surgery for a time period determined by a previous pilot study. PCA is then post-operatively until anticoagulation is stopped, and then will be resumed for four years post revision surgery. Measurement of changes in glucose control, immunity, will be measured over the first 3 months post-revision, and the post-revision reinfection rate over the full 4 years will be compared to a cohort rate
- Conditions
- Prosthetic Joint Infection
- Being tested
- Oral PCA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral PCADietary supplement
PCA 1,000 mg BID until surgery, held until anticoagulation, and resumed at 1,000 mg daily for 4 years
| Study group | Role | What they receive |
|---|---|---|
| PCA administraton | Other | Not described Receives: Dietary Supplement: Oral PCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in immunity factor CXCL9 from 0 to 3 months
Measured: 0 and 3 months
Change in HbA1c from 0 to 3 months
Measured: 0 and 3 months
Secondary outcomes (1)
Reinfection rate after revision for prosthetic joint infection
Measured: 0 to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startJan 2027 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionDec 2028 (estimated)
Why it stopped: Could not find a collaborating orthopedic surgeon.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic Joint InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Dean Reeves Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Dean Reeves, Dr. Dean Reeves Clinic
- Investigators
- Kenneth D Reeves, M.D., Principal investigator, K. Dean Reeves, M.D., P.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591741
- Sponsor's protocol ID
- PCAinPJI-01
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2024
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dietary Protocatechuic Acid (PCA) on the Function and Structure of Participants With Knee Prosthetic Joint Infection (PJI) as Measured by Standard Biomarkers
- ClinicalTrials.gov ID
- NCT06591741
- Acronym / sponsor ID
- PCAinPJI-01
- Conditions
- Prosthetic Joint Infection
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Could not find a collaborating orthopedic surgeon.
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dr. Dean Reeves ClinicUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine if dietary protocatechuic acid (PCA) will affect health biomarkers in patient undergoing revision surgery for a knee prosthetic joint infection
Detailed description
Patients who are scheduled to undergo revision surgery for a knee prosthetic joint infection are given PCA prior to surgery for a time period determined by a previous pilot study. PCA is then post-operatively until anticoagulation is stopped, and then will be resumed for four years post revision surgery. Measurement of changes in glucose control, immunity, will be measured over the first 3 months post-revision, and the post-revision reinfection rate over the full 4 years will be compared to a cohort rate
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCA administraton | Other | Dietary Supplement: Oral PCA |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 3 weeks or more after total knee arthroplasty
- One or more symptoms of infection, including redness, swelling, pain, increasing range of motion loss, fever, nausea, and loss of appetite.
- WBC count of aspirate >50,000 cells per μL
Key exclusion criteria (1 listed)
- Not willing to undergo blood draw at 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral PCAPCA 1,000 mg BID until surgery, held until anticoagulation, and resumed at 1,000 mg daily for 4 years | Dietary supplement | PCA administraton |
Primary outcome
Change in immunity factor CXCL9 from 0 to 3 months
Time frame: 0 and 3 months
Change in HbA1c from 0 to 3 months
Time frame: 0 and 3 months
1 secondary outcome
Reinfection rate after revision for prosthetic joint infection
Time frame: 0 to 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth D Reeves, M.D. principal investigator
K. Dean Reeves, M.D., P.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral PCA in people with Prosthetic Joint Infection, run by Dr. Dean Reeves Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in immunity factor CXCL9 from 0 to 3 months (time frame: 0 and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.